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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

1832-A-0001 — Class I MDR by Mekalasi Oy

MD Atlas
Mekalasi Oy

EUDAMED last updated this device on Sep 22, 2023

1832-A-0001

6430074263997WQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mekalasi Oy
UDI-DI code: 06430074264062
Reference / catalog number: 1832-A-0001

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Manufacturer information

Organization name: Mekalasi Oy
SRN: FI-MF-000003102
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 06430074264062
Basic UDI-DI: 6430074263997WQ
Reference / catalog number: 1832-A-0001
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Augenmarker is an indication tool for medical doctors to mark the place of surgery or injection on the patient’s eye. The devices are used for example in cataract surgery. The doctor chooses which end he or she wants to use and puts some marker colour into that end of the device and with that marks the injection or surgery place on to the patient’s eye. The device can be sterilized before use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q020203CORNEAL MARKERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.